THE DETAILS COMPLETE STUDY OFF WHO ICH AND GMP GUIDELINES REGARDING FOR DRUG SAFETY AND EFFICIENCY OF DRUG
Akshaykumsar Sahebrao Wathore, Dr. Sunil S. Jaybhaye, Prof. Saurabh M. Bondre
Institute of Pharmacy, Badnapur, Dist. Jalna., Maharashtra
Abstract
The International Conference on Harmonization (ICH) of Technical Requirements is a unique project for Registration of Pharmaceutical products which are intended for human use. This brings together the regulatory authorities of Europe, Japan and United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The purpose is to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.Herbal products are widely used worldwide. In the context of globalization, quality control of these products has become an increasingly important issue not only for the consumers but also for regulators and manufacturers. Laws, regulations and guidelines stipulating requirements of good manufacturing practice (GMP) of herbal products differ worldwide and harmonization is yet to be achieved. The World Health Organization (WHO) plays a pivotal role in setting global standards for the safety and efficacy of pharmaceutical products. This study offers an in-depth analysis of WHO guidelines with a focus on the regulatory framework, evaluation processes, and international harmonization efforts that underpin drug safety and efficacy.
Keywords: Pharmaceutical Quality Assurance, Drug Safety Regulations ;Drug Efficacy Standards;; Pharmaceutical Regulatory Compliance; WHO GMP Guidelines ICH Guidelines
Journal Name :
VIEW PDF
EPRA International Journal of Research & Development (IJRD)
VIEW PDF
Published on : 2025-06-04
Vol | : | 10 |
Issue | : | 6 |
Month | : | June |
Year | : | 2025 |